Neuromuscular Electrical Stimulation and Voluntary Muscle Contraction in Chronic Hemiplegic Stroke Patients

NCT07458750 | Active Not Recruiting

• 1 other identifier: UOL/IREB/25/12/0013
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This single-blinded randomized controlled trial will be conducted at the Physical Therapy Department of the University of Lahore Teaching Hospital after approval from the Institute Research Ethics Board. Eligible participants will be recruited and randomly allocated into two groups by lottery method: Group A (control group) receiving conventional physical therapy, and Group B (experimental group) receiving neuromuscular electrical stimulation (NEMS) combined with voluntary muscle contraction. NEMS will be applied to the tibialis anterior, extensor hallucis longus, and extensor digitorum longus with standard stimulation parameters, while participants perform active dorsiflexion during stimulation. The assessor will remain blinded to group allocation. Outcome measures including spasticity (Modified Ashworth Scale), active range of motion (goniometer), and muscle strength (manual muscle testing) will be evaluated at baseline, 6 weeks, and 12 weeks.

Conditions

Stroke

Keywords

Hemiplegia

Outcome Measures

Primary Outcomes (3)

• Modified Ashworth scale

  The Modified Ashworth Scale is a clinical tool used to assess muscle spasticity by measuring resistance during passive soft-tissue stretching. It grades the increase in muscle tone on a scale from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates the affected part is rigid in flexion or extension. It is a widely used and reliable method for evaluating the severity of spasticity in patients with neurological or musculoskeletal conditions.

  12 weeks

• Goniometery

  A goniometer is an instrument that either measures an angle or allows an object to be rotated to a precise angular position.

  12 weeks

• Manual muscle testing

  Manual Muscle Testing is a standardized clinical assessment used to evaluate the strength of individual muscles or muscle groups based on the examiner's application of resistance. Muscle strength is graded on a six-point scale (0-5), where 0 indicates no muscle contraction and 5 represents normal strength against full resistance. It is a reliable and widely used method to assess motor function, recovery, and the effectiveness of therapeutic interventions.

  12 weeks

Study Arms (2)

Conventional physiotherapy

EXPERIMENTAL

Conventional physiotherapy Participants in the comparative group will receive conventional physiotherapy treatment including placebo application of neuromuscular electrical stimulation (NEMS), weight-bearing exercises, stretching, proprioceptive neuromuscular facilitation (PNF) techniques, tapping, passive range of motion (PROM) exercises, and dorsiflexor strengthening exercises. The placebo NEMS will be applied in the same manner as the active stimulation but without any therapeutic current. Each session will be supervised by a physiotherapist. Treatment will be conducted as per the study protocol, and all participants' responses, complaints, and discomforts during the sessions will be monitored and recorded using a patient record sheet.

Other: Conventional physiotherapy; Other: Neuromuscular electrical stimulation and voluntary muscle contraction

Neuromuscular electrical stimulation + Voluntary muscle contraction

EXPERIMENTAL

Experimental Group (NEMS + Voluntary Muscle Contraction) Neuromuscular Electrical Stimulation (NEMS) with Voluntary Muscle Contraction Participants in the experimental group will receive neuromuscular electrical stimulation (NEMS) combined with voluntary muscle contraction of the dorsiflexors. Surface electrodes will be placed over the tibialis anterior, extensor hallucis longus, and extensor digitorum longus muscles. Stimulation parameters will be set as follows: pulse width = 200 microseconds, on time = 5 seconds, off time = 5 seconds, frequency = 20 Hz, waveform = symmetrical biphasic square wave. Participants will be instructed to voluntarily contract the dorsiflexors during each stimulation pulse. The stimulation intensity will be adjusted according to patient comfort to avoid fatigue. Each session will be administered by a trained physiotherapist following the standardized protocol. Any discomfort or adverse response during the procedure will be documented in the patient

Other: Conventional physiotherapy; Other: Neuromuscular electrical stimulation and voluntary muscle contraction

Interventions

Conventional physiotherapy OTHER

Conventional physiotherapy Participants in the comparative group will receive conventional physiotherapy treatment including placebo application of neuromuscular electrical stimulation (NEMS), weight-bearing exercises, stretching, proprioceptive neuromuscular facilitation (PNF) techniques, tapping, passive range of motion (PROM) exercises, and dorsiflexor strengthening exercises. The placebo NEMS will be applied in the same manner as the active stimulation but without any therapeutic current. Each session will be supervised by a physiotherapist. Treatment will be conducted as per the study protocol, and all participants' responses, complaints, and discomforts during the sessions will be monitored and recorded using a patient record sheet.

Conventional physiotherapy; Neuromuscular electrical stimulation + Voluntary muscle contraction

Neuromuscular electrical stimulation and voluntary muscle contraction OTHER

Experimental Group (NEMS + Voluntary Muscle Contraction) Neuromuscular Electrical Stimulation (NEMS) with Voluntary Muscle Contraction\<br\>\<br\>Participants in the experimental group will receive neuromuscular electrical stimulation (NEMS) combined with voluntary muscle contraction of the dorsiflexors. Surface electrodes will be placed over the tibialis anterior, extensor hallucis longus, and extensor digitorum longus muscles. Stimulation parameters will be set as follows: pulse width = 200 microseconds, on time = 5 seconds, off time = 5 seconds, frequency = 20 Hz, waveform = symmetrical biphasic square wave. Participants will be instructed to voluntarily contract the dorsiflexors during each stimulation pulse. The stimulation intensity will be adjusted according to patient comfort to avoid fatigue. Each session will be administered by a trained physiotherapist following the standardized protocol. Any discomfort or adverse response during the procedure will be documented in the patient.

Conventional physiotherapy; Neuromuscular electrical stimulation + Voluntary muscle contraction

Eligibility Criteria

• Age: 43 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of between 43 to 83 years of age
• Diagnosed with chronic stroke (≥6 months in duration) with motor deficits resulting in hemiplegia
• Mild ankle dorsiflexion possible
• MAS score of ≤3 for dorsiflexors to the ankle joint
• Be self-mobility either with or without aids .

You may not qualify if:

• Parkinson's or multiple sclerosis affecting the nervous systems of the body
• Skeletal disorders that hinder the ability of the limb
• Pacemaker or any condition which may lead to a contraindication with NMES
• Spasticity (MAS ≥ 3)
• Current botulinum toxin injections in the lower limb that developed the spasticity
• Patients with any cognitive impairment (MMSE \< 24)

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

University of lahore teaching hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

• Gillard, J. H., Parrish, T. B., & Mossa-Basha, M. (2021). Stroke imaging advancements. Neuroimaging Clinics of North America, 31(1), 1-17. https://doi.org/10.1016/j.nicna.2020.11.001

  BACKGROUND

• Fugl-Meyer, A. R., Jääskö, L., Leyman, I., Olsson, S., & Steglind, S. (1975). The post- stroke hemiplegic patient: A method for evaluation of physical performance. Scandinavian Journal of Rehabilitation Medicine, 7(1), 13-31.

  BACKGROUND

• Feigin, V. L., Norrving, B., & Mensah, G. A. (2017). Global burden of stroke. The Lancet Neurology, 16(11), 877-897. https://doi.org/10.1016/S1474-4422(17)30283-0

  BACKGROUND

• Doucet, B. M., Lam, A., & Griffin, L. (2012). Neuromuscular electrical stimulation for skeletal muscle function. Yale Journal of Biology and Medicine, 85(2), 201-215.

  BACKGROUND

• Chen, H., Lin, Y., Chen, C., & Tang, Y. (2022). NMES and VMC for dorsiflexion and mobility improvements in chronic stroke. Journal of Neurorehabilitation, 29(6), 378- 387. https://doi.org/10.1016/j.neurorehab.2022.05.004

  BACKGROUND

• Busk H, Skou ST, Lyckhage LF, Arens CH, Asgari N, Wienecke T. Neuromuscular Electric Stimulation in Addition to Exercise Therapy in Patients with Lower Extremity Paresis Due to Acute Ischemic Stroke: A proof-of-concept randomised controlled trial. J Stroke Cerebrovasc Dis. 2021 Oct;30(10):106050. doi: 10.1016/j.jstrokecerebrovasdis.2021.106050

  BACKGROUND

• Burridge, J., Wood, D., Taylor, P., & Swain, I. (2014). Feasibility study on NMES and VMC for dorsiflexion recovery. Archives of Physical Medicine and Rehabilitation, 95(4), 817-824. https://doi.org/10.1016/j.apmr.2013.12.011

  BACKGROUND

• Bohannon, R. W., & Smith, M. B. (1987). Interrater reliability of a modified Ashworth scale of muscle spasticity. Physical Therapy, 67(2), 206-207. https://doi.org/10.1093/ptj/67.2.206

  BACKGROUND

• ● Benjamin, E. J., Muntner, P., Alonso, A., Bittencourt, M. S., Callaway, C. W., Carson, A. P., ... & Virani, S. S. (2019). Heart disease and stroke statistics-2019 update: A report from the American Heart Association. Circulation, 139(10), e56-e528. https://doi.org/10.1161/CIR.0000000000000659

  BACKGROUND

• Ahmed, A., et al. (2019). Evaluation of NMES and VMC for ankle control in chronic stroke. Journal of Stroke and Cerebrovascular Diseases, 28(12), 3417-3425.

  BACKGROUND

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Abdul Moiz Hussain Khan, Mspt- neuro

  University of Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study will be single and assessor blinded. Participants will be masked about other groups but they will know what treatment they will be receiving or what exercises they will be doing. Principal investigator would also not be masked or blinded because investigator would be applying the techniques on participants of both group. So participant and and principal investigator cannot be blinded. Only assessor will be blinded and he will take outcome measures without knowing the problem and treatment techniques.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: February 10, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)